Smith & Nephew Recalls Misidentified PeriLoc Targeter Handle
Smith & Nephew is recalling 3 units of a PeriLoc Targeter handle that was incorrectly marked as a left-hand part.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling/marking error (misidentification of a surgical instrument) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling 3 units of the PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE. The affected product is identified by Product Number 71173400 and Lot Number 16GM20026.
The recall was initiated because the 4.5MM PeriLoc Targeter right-hand part was anodized green and incorrectly marked as a left-hand part. This misidentification could lead to the use of the wrong instrument during surgical procedures.
The affected units were distributed nationwide in the United States, including in the states of Indiana and Tennessee. The product is indicated for fixation of pelvic, small, and long bone fractures in adult and pediatric patients. Users should stop using the affected units and contact Smith & Nephew for instructions.
The recalled product
- Product
- PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of…
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Number: 71173400
- Lot Number: 16GM20026
Distribution
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